- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development , integration, and execution of ... provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study: provide input on the development of study protocol (design, ... Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... diverse external providers for clinical trials, companion diagnostics trials, clinical development , and regulatory submissions. This position may propose… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... Essential Functions Leads pricing and contracting strategy, playbook, and guideline development for all new product launches within responsible therapeutic area,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine ... Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... preparation of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety-related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... with global functions including but not limited to Commercial, Marketing, Medical, Clinical Development , Public & Government Affairs.Responsibilities- Lead the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in applied statistics ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Site-Launch activities and associated teams for internal and external sites and development projects. Serve as the main interface to internal and external ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
